Protocol summary
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Study aim
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Determining the Effect of Virtual Psychological Hot Wash on Pre-hospital Emergency Staff Anxiety and Stress
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Design
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Clinical trial with control group, with parallel groups, without blinding, randomized, phase 3 on pre-hospital emergency staff. Excel software rand function was used for randomization.
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Settings and conduct
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The research site will be the Accident Management Center of Qom University of Medical Sciences. Before the intervention, participants' stress and anxiety scores will be measured in both intervention and control groups. Then a virtual psychological hot wash program will be performed for the intervention group for one month. No intervention will be performed for the control group. 30 and 72 days after the intervention, the stress and anxiety scores in both intervention and control groups will be measured, and the obtained data will be compared.
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Participants/Inclusion and exclusion criteria
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Pre-hospital emergency staff with one year of work experience will participate in this study. The study will not include pre-hospital emergency staff with a history of untreated mental illness.
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Intervention groups
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Intervention group: Pre-hospital emergency staff will participate in the virtual psychological hot wash program after the end of the night shift and with the presence of a psychologist in the pre-hospital emergency management room through the cyberspace of Adobe Connect software.
Control group: Pre-hospital emergency services will not receive any intervention.
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Main outcome variables
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Stress, Anxiety
General information
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Reason for update
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Unexpected delay in sampling time.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121107011399N7
Registration date:
2022-05-09, 1401/02/19
Registration timing:
prospective
Last update:
2024-09-21, 1403/06/31
Update count:
1
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Registration date
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2022-05-09, 1401/02/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-07-22, 1403/05/01
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Expected recruitment end date
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2024-10-22, 1403/08/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effect of Virtual Psychological Hot Wash on Pre-hospital Emergency Staff Anxiety and Stress
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Public title
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The Effect of Psychological Hot Wash on Anxiety and Stress
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Degree or bachelor's degree in medical emergencies
Work experience for at least one recent year
The employee does not suffer from previously known mental and physical disorders.
Exclusion criteria:
Unwillingness to participate in research
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Age
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From 22 years old to 52 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done in two steps. The first step will be to select the samples from the research community using a table of random numbers. Since the number of pre-hospital technicians working in Qom Accident Management Center is known (253 people), each research community member will be given a code. Then the samples (60 people) will be randomly selected using the Rand company function. In the next step, 60 selected codes are divided into two groups of intervention and control using the lottery method.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-01-02, 1400/10/12
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Ethics committee reference number
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IR.MUQ.REC.1400.212
Health conditions studied
1
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Description of health condition studied
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Anxiety
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ICD-10 code
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F06.4
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ICD-10 code description
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Anxiety disorder due to known physiological condition
2
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Description of health condition studied
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Stress
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ICD-10 code
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F43
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ICD-10 code description
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Reaction to severe stress, and adjustment disorders
Primary outcomes
1
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Description
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Anxiety score in the Spielberger Anxiety Questionnaire
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Timepoint
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Measurement of anxiety at the beginning of the study (before the intervention) and 30 and 72 days after the implementation of the virtual hot wash program
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Method of measurement
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The Spielberger Anxiety Questionnaire
2
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Description
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Stress score in Cohen's Perceived Stress Questionnaire
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Timepoint
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Measurement of stress at the beginning of the study (before the intervention) and 30 and 72 days after the implementation of the virtual hot wash program
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Method of measurement
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The Cohen's Perceived Stress Questionnaire
Intervention groups
1
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Description
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Intervention group: Virtual Psychological Hot Wash sessions will be held immediately after the night shift and with the presence of a psychologist (a fixed person in all stages) in the pre-hospital emergency management room through the virtual space of Adobe Connect software for one month. The steps of psychological hot washing will be done as follows: first, what happened will be discussed (reality stage); In the next stage, how the person thinks about problems and his decisions about the processes involved and personal meanings (thinking stage); Then the domain associated with the emotional response (reaction phase); And other reactions experienced (symptom stage) will be measured. In the next step, training on coping strategies will be done. Finally, in the re-entry phase, this process is reviewed and ends with a discussion of the issues and a return to daily life.
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Category
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Treatment - Other
2
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Description
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Control group: Pre-hospital emergency staff in the control group will not receive any intervention.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ghoum University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Participants' personal data will be shared after their names are removed.
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When the data will become available and for how long
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Data access will start from the beginning of 2025 for six months.
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To whom data/document is available
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The reviewers of the research project and the reviewers of the scientific article obtained from this research will be allowed to access the data.
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Under which criteria data/document could be used
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The data will be sent to the reviewers.
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From where data/document is obtainable
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To receive data, write to aebrahimian@muq.ac.ir.
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What processes are involved for a request to access data/document
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The person who needs to review the data sends an email to aebrahimian@muq.ac.ir, in which he introduces himself and specifies the reason for the need for the data. If the applicant is one of the reviewers, the data will be sent to him/ her via email.
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Comments
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